Obese children ought to be included in the Omega-3 research
U.S. experts said on Wednesday that companies developing fat-fighting drugs should include severely obese children in their studies but were less supportive of targeting moderately overweight adults without health problems.
Panelist Dr. Lynne Levitsky, head of pediatric endocrinology at Massachusetts General Hospital, said a "higher assurance of safety" would be needed before including people who are heavy but not obese.
In 1997 the Food and Drug Administration had to pull Wyeth's so-called "fen-phen" cocktail from the market after it was linked to heart troubles.
The members of a FDA advisory committee were more certain that drug makers should include children in their research, but only those with a high body mass and severe health problems, informs Reuters.
According to Washingtonpost the Food and Drug Administration said yesterday that fish and other foods and dietary supplements containing omega-3 fatty acids can claim on their labels that they help reduce the risk of heart disease, even though the supporting scientific evidence is still unfolding.
In recent years, a growing number of studies have prompted many cardiologists to prize omega-3 fatty acids for their apparent ability to protect the heart against inflammation that can lead to blocked arteries and to reduce the risk of often-fatal heartbeat irregularities.
"This new qualified health claim for omega-3 fatty acids should help consumers as they work to improve their health by identifying foods that contain these important compounds," said acting FDA Commissioner Lester M. Crawford, noting that an estimated 500,000 Americans die each year from heart disease.
Schneeman said these restrictions are based on the potential dangers of ingesting too much omega-3 fatty acid. The risks include a reduced ability for blood to clot, she said.
Ellwood noted that there are restrictions on using this health claim. "There are disqualifying levels for amounts of saturated fat and cholesterol. They [manufacturers] have to meet certain regulatory requirements before they could make the claim," she said.
Earlier this year, the FDA approved a similar qualified health claim for walnuts, which contain other properties that appear to reduce the risk of heart disease, informs Forbes.